Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US



Status:Completed
Conditions:Vaccines, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:January 1, 2009
End Date:August 2, 2012

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Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK580299) in Female American and Canadian Subjects Who Had Received Control Vaccine in Study 580299/008

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV
vaccine GSK580299 in female subjects who took part in study 580299/008 and received the
control vaccine (Hepatitis A vaccine).


Inclusion Criteria:

- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study

- A subject previously enrolled in the primary study (NCT00122681), who received the
active control hepatitis A vaccine, and who cannot receive commercially available
HPV-16/18 L1 VLP AS04 vaccine because the vaccine has not yet been granted licensure
in the subject's country or because the subject is above the age for which the vaccine
is licensed.

- Written informed consent must be obtained from the subject prior to enrolment.

- A woman aged 18 years or older, at the time of the first vaccination in this study.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Subjects must not be pregnant. Absence of pregnancy should be verified with a urine
pregnancy test.

- Subject must be of non-childbearing potential, or if she is of childbearing potential,
she must practice adequate contraception for 30 days prior to vaccination, have a
negative pregnancy test and continue such precautions for 2 months after completion of
the vaccination series.

Exclusion Criteria:

- Pregnant or lactating female. Enrolment should be deferred until three months after
pregnancy has been completed or after lactating has ceased.

- A woman planning to become pregnant or likely to become pregnant (as determined by the
investigator) or planning to discontinue contraceptive prevention during the study
period and up to two months after the last vaccine dose.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned use
during the study period and the extended safety follow-up period.

- Concurrently participating in another clinical study at any time during the study
period, in which the subject has been or will be exposed to an investigational or
non-investigational product (pharmaceutical product or device).

- Previous vaccination against HPV or planned administration of another HPV vaccine
during the study other than that foreseen by protocol.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
within 30 days (i.e. Day 0-29) of each dose of vaccine. Administration of routine
meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus
and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study
vaccine is allowed. Enrolment will be deferred until the subject is outside of
specified window.

- Previous administration of components of the investigational vaccine.

- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccine.

- Hypersensitivity to latex.

- Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
haematological, hepatic or renal functional abnormality, as determined by previous
physical examination or laboratory tests, which in the opinion of the investigator
precludes administration of the study vaccine.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- Cancer or autoimmune disease under treatment.

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Acute disease at the time of enrolment.
We found this trial at
38
sites
Minneapolis, Minnesota 55404
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Minneapolis, MN
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Albuquerque, New Mexico 87109
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Albuquerque, NM
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Arkansas City, Kansas 67005
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Arkansas City, KS
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Augusta, Georgia 30909
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Augusta, GA
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Austin, Texas 78705
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Austin, TX
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Bardstown, Kentucky 40004
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Bardstown, KY
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Carnegie, Pennsylvania 15106
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Carnegie, PA
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charlottesville, Virginia 22903
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Charlottesville, VA
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Clearwater, Florida 33759
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Clearwater, FL
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Cleveland, Ohio 44195
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Cleveland, OH
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Denver, Colorado 80206
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Denver, CO
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Edmonton, Alberta
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Edmonton,
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Erie, Pennsylvania 16507
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Erie, PA
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Honolulu, Hawaii 96813
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Honolulu, HI
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Houston, Texas 77030
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Houston, TX
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Iowa City, Iowa 52242
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Iowa City, IA
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Lebanon, New Hampshire 03756
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Lebanon, NH
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Louisville, Colorado 80027
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Louisville, CO
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Louisville, Kentucky 40202
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Louisville, KY
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Miami, Florida 33136
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Miami, FL
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Morristown, New Jersey 07962
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Morristown, NJ
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New Bern, North Carolina 28562
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New Bern, NC
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New York, New York 10032
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New York, NY
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Newton, Kansas 67114
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Newton, KS
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Omaha, Nebraska 68131
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Omaha, NE
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Pleasant Hills, Pennsylvania 15236
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Pleasant Hills, PA
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Portland, Oregon 97227
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Portland, OR
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Poughkeepsie, New York 12601
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Poughkeepsie, NY
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San Diego, California 92111
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San Diego, CA
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San Francisco, California 94115
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San Francisco, CA
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Spokane, Washington 99208
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Spokane, WA
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Tulsa, Oklahoma 74105
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Tulsa, OK
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Webster, Texas 77450
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Webster, TX
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Wenatchee, Washington 98801
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Wenatchee, WA
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West Palm Beach, Florida 33409
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West Palm Beach, FL
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Wichita, Kansas 67207
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from
Wichita, KS
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